Tampon



A. DRAGHI July 7, 1959 TAMPON Original Filed Dec. 5, 1955 2 Sheets-Sheetl INVENToR l ,D :uffa v ATTORNE July 7, |959 A. DRGHI R. 24,666

' TAMPON Original Filed Dec. 5, 1955 v f 2 Sheets-Sheet 2 INVENTORAna/,re ,D rayh rl United States Patent() TAMPON Andr Draghi, Stamford,Conn.

Original No. 2,844,150, dated July 22, 1958, Serial No. 550,981,December 5, 1955. Application for reissue March 16, 1959, Serial No.799,828

3 Claims. (Cl. 12S-285) Matter enclosed in heavy brackets appears in theoriginal patent but forms no part of this reissue specilieation; matterprinted in italics indicates the additions made by reissue.

This invention relates to a tampon for detection of cancer.Moreparticularly it relatestoa tampon as a means for mass screening anddetection of cancer of the pelvic region.

The frequency of advanced cancer of the pelvic region presents to themedical profession a disturbing picture. One author states that only arelatively smallpercentage of the cases of cancer of the cervix isdetected in the early stage ofthe disease. This is .in spite of thevarious methods to detect cancer of the cervix which have been developedand are being used' by gynecologists today. Among vthe practicalbarriers to prompt diagnosis is the inability and the reluctance of manywomen to present themselves periodically to a physician for agynecological examination whereby early evidence of cancer may bedetected; this inability and reluctance is a direct cause of the highpercentage of advanced cancer which occurs or develops in the pelvicregion and particularly in the region of the cervix uteri. Furthermorethe protracted gynecological examination of the patient which isnecessary to obtain full diognostic information, is time consuming forthe physician and nurse and accordingly any such routine periodicalexamination may be prohibitively expensive for the patient, and themedical organization undertaking it.

Complete diagnosis to determine whether and to what extent one hascancer must require a thorough gynecological and pelvic examination andbiopsy. Preliminiary diagnosis to determine if there are present anyindicia of cancer however, may be asserted by taking a sample of cellswhich are present in the cervical canal and the vagina and thesubsequent microscopic analysis of these cells. While a thoroughgynecological examination and biopsy should be performed in those casesin which the preliminary diagnosis indicates cancer, the preliminarydiagnosis can serve to screen many women and thus initiate the earlytreatment of those who have indications of cancer.

It is therefore an object of this invention to provide a means for massscreening for cytological detection of carcinomas of the pelvic region.

A further object of this invention is to provide through the cooperationof the patient herself, an accurate, inexpensive means by which cellspresent in the pelvic region can be collected and thus screen largenumbers of women thereby reducing the percentage of cases havingadvanced pelvic cancer.

Another object of this invention is to provide a means for samplingvaginal cells, which can be inserted by the patient herself, and willprovide satisfactory smears for laboratory evaluation without thenecessity for elaborate clinical facilities.

In accordance with the present invention a cancer de- Re. 24,666Reissued July 7, 1959 lee tection tampon is inserted into the vaginalcavity in a manner like that for the well known catamenial tampon andremains therein for a time specified by the physician. The tampon isthen removed by the patient and given to a nurse who makes a smear on aslide according to the method described in articles appearing in vol. 7,No. 6 of Cancer at pages 1182 et. seq. and 1185 et. seq. and appearingin vol. 159, No. 12 of The Journal of the American Medical Associationat page 1177 et seq.

A better understanding of the invention may be obtained by reference tothe accompanying drawings in which:

Figure l is a perspective view of one type of jacket according to theinvention which is placed over a supporting body;

Figure 2 is a perspective view of a vaginal supporting body suitable foruse with the jacket of Figure 1;

Figure 3 is a perspective view of the jacketed tampon ready for use;

Figure 4 is a perspective view of another type of jacket suitable,according to the invention, to be assembled over a cotton pad and theassembly compressed to form the detection tampon;

Figure 5 is a perspective view of an uncompressed cotton pad for usewith the jacket of Figure 4;

Figure 6 is a perspective view of the assembled detection tampon showingthe jacket turned inside out so that the seam is on the inside andshowing the jacket ltted over one end of the uncompressed cotton pad andthe two sewn together with the string; and

Figure 7 is a perspective view of the assembled detection tampon ofFigure 6 after it has `been compressed into a cylindrical form.

Referring to Figures l and 2 there is shown supporting body 10 similarin size and shape to the type generally used for catamenial tampons.Body 10 is made of a size and of a material which is sufficientlyflexible to be comfortable carried in the vaginal cavity, in a preferredexample this may be about 1/2" x 2%. In the embodiment illustrated acotton liber body is employed as the supporting means and is covered -byjacket 12.

Jacket 12 is formed from a piece of material sewed into a generallyround tube with a closed but enlarged cap 13. Jacket 12 is made so thatit covers one end and extends approximately one-half the length of body10. The fins of material 16 along the seams 18 are on the inside of thejacket leaving the outside smooth. In the present embodiment jacket 12is made out of a closely woven, sheer cloth which is manufactured from anonabsorbent, relatively line, continuous filament yarn such as nylon.

Figure 3 shows body 10 and jacket 12 assembled into a detection tampon14 which embodies features of the invention. Tampon 14 is shaped into agenerally round form. One end of body 10 is covered by closed end 13 ofjacket 12 and the other end is attached to a removal string 22. Removal[strip] string 22 is sewed into the tampon 14 by the same stitching thatsecurely aixes jacket 12 to body 10 forming tampon 14.

Another embodiment of the invention is shown in Figures 4, 5, 6 and 7.The jacket 12a of Figure 4 is slipped over cotton pad 10a shown inFigure 5. The jacket 12a is similar to jacket 12 shown in Figure l.Jacket 12a is a closely woven sheer cloth manufactured from relativelynon-absorbent, continuous filament such as nylon. The cloth when foldedback upon itself, as shown in Figure 4, is stitched along one edgeextending from the fold and the edge opposite to the fold; but a verysatisfactory jacket can be made from a longer and narrower piece ofcloth folded back upon itself and stitched along opposite edges adjacentto the fold. Or a tubular fabric of the required width can be sewnacross 3 one end; Thus it vvill be seen that the [essential] featureessentially identifying Fig'. 4 with these latter alternatives is thatthe jacket is closed on the sides and one end, and open at its other endand of a size adapted to containV cotton' pad 1'0a" as shown in Figure5.

After the jacket 12a has been sewn as `,showt/n in Eigu1e 4', it isturned inside out leaving al smooth' exterior suface. t

Figurey 6 shows an uncompressed cotton pad' l10'a and jacket 12aassembled and stitched' as at 47 downn the center and to Withdi'awalcord 22a forming uncompressed tampon 14a. n V y t Figure 7 shows theassembled tampon14b comprising jcket'1`2a land cotton pad 10a after' thetampon has been compressed into a' cylindrical shape.y Surplus materialat the top of the jacket forms ya chefs cap 13a.

The jacketY 12 and 12a holds Whatever cells co1- lected from the' b'o'dycavity oil the surface of thjjkt: Because the cloth of the jacket isnon-absoibe'nt these cells are notdehydate'dL and thus remain in"l aifelativ'ely moisi:A conditionr which' enagtilesr a' more accurate'clinical evaluation. It has also been fond'niost satisfacfdy forcollection of vaginal smears that the exteioi suvlface Z and 20aof thejacket 1'2 and 12a" be relatively smooth.

The n of material resulting from'the seam slild the'efoi'ebe made on theinside. y n The enlarged cap 13 and 13a which extends farthest intothevaginal canal collects and retains in noist form many cells; While thespecific reasons for theitnprovd sampling'- through use of the' enlargedcap 13 and 13a remain obscure at this time tests haver proven that alarge percentage of cells arel collected on thecap 13 and 13a` and by`using a tamponiwith such a cap thesa'rnplig` of cells from the vagina isLgreatly improved. n The pliability of tampons 14,l 1`4`a and" l4bpermits the easy removal of the collected cells by evenly sin'eiat-A ingonto a microscope slide, with or withouty squeezing with finger pressureagainst its sides and advantageously rotatingthe tampon in contactwithvthe slide.y

In the embodiments I have described the tampon is comprised of a jacketof non-absorbent, relatively tine, continuous filament yarn such asnylon and a supporting body of cotton fiber. Laboratory tests haveconclusively indicated that the use of the non-absorbent supporting bodyis also practical for the collection of cells. Thus, for the collectionof cellsuawplastic, rubber or other nonabsorbent supporting body withthe nylon like jacket can be used.

1. A vaginal type tanpn compised of a supporting to said body andciviing one"v end' of said supporting body and the adjacentpqrtiqnofutlhewbody, but extending beyondnit in a loose capaid acket bern a`tine-mes u f L j. Hg t a1 it 1255.279@ A Sep,r.29,;19,25 2267.030 H.nea 2311941

